1 Introduction Biomarker discovery has rapidly progressed from a classical empirical approach to a high-priority, technology-supported research activity. According to the Food and Drug Administration's (FDA) Biomarkers, EndpointS and other Tools glossary ( ), a biomarker is a defined…
Acknowledgments The authors are grateful for figure contributions for this chapter. We would like to thank Dr. Robert Maronpot and Dr. Robert Sills of NIEHS, Dr. Alan Johnson of the Duke University Center for In vivo Microscopy, Dr. Marty Pomper, Dr.…
1 Introduction The age of digitalization has arrived in light microscopy. While the current practice of toxicologic pathology remains largely based on the light microscopic evaluation of stained tissue sections, it is no longer limited to it. Thanks to the…
1 Introduction Advances in cell and molecular biology have engendered a wide range of techniques to investigate mechanisms of disease or toxicity that can be used to augment traditional morphologic tools used in toxicity testing. In the team-oriented scientific world…
1 Introduction 1.1 Value of Clinical Pathology Testing Clinical pathology testing is a key component of nonclinical safety studies that evaluate the potential toxicity of test articles including therapeutic agents (new chemical entities and biologics), pesticides, and industrial chemicals to…
1 Introduction Traditionally trained veterinary and medical pathologists often encounter unanticipated challenges during their transition from diagnostic pathology to the regulatory-driven environment of toxicologic pathology. During their initial years of training and diagnostic effort, pathologists typically serve both clinical and…
Acknowledgments The authors would like to thank David Sabio and Experimental Pathology Laboratories for assistance with figure generation. We foresee cancer research as an increasingly logical science, in which complexities are manifestations of a small set of underlying organizing principles.…
1 Introduction Developmental and reproductive toxicity (DART) studies represent an important component of the toxicology programs supporting both the development of novel therapeutics and the evaluation of environmental, agricultural, and industrial chemicals. Reproductive toxicity generally refers to adverse effects on…
1 Introduction 1.1 Importance of Morphologic Assessment in Toxicologic Pathology Microscopic morphologic assessment is a major component of experimental toxicity studies using laboratory animal models. To realize the full value of these studies, toxicologic pathologists should accurately classify all adverse…
1 Introduction: Definition of Pharmacodynamics and Toxicodynamics In simple terms, pharmacodynamics (PD) and toxicodynamics (TD) describe the relationship between exposure (concentration at the site-of-action) of the drug, toxicant, or toxin (xenobiotic) and the extent of resulting effect on the body…